EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations
EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a regulatory compliance failure (lack of registration/quality system) rather than a physical defect or reported illness. Per the rubric, this aligns with 'voluntary precautionary recalls' or minor issues where no harm is reported, fitting the Moderate (2) category.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling three units of the GelPort Laparoscopic System, specifically the sterile, single-use Pouch (Tyvek/Mylar) with OEM Catalog number C8XX2N0NCE. The product is manufactured by Applied Medical and repackaged by EXP. The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system, relying instead on its vendors' registrations and quality systems.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. The devices are intended for use in general and plastic surgery. No specific dates of distribution or additional lot numbers are provided in the source text.
Consumers and healthcare facilities should stop using the affected products and contact EXP Pharmaceutical Services Corp for further instructions on return or replacement. The recall is driven by regulatory compliance failures rather than reported product defects or patient injuries.
The recalled product
- Product
- Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- OEM Catalog number C8XX2N0NCE.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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